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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K925721
Device Name KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE
Applicant
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Applicant Contact SAMUEL CONSOL
Correspondent
EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER,  NY  14650
Correspondent Contact SAMUEL CONSOL
Regulation Number892.2030
Classification Product Code
LMA  
Date Received11/12/1992
Decision Date 02/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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